Dentsply Sirona Gutta-Smart Manual

Gutta‑Smart™
Directions for Use
EN

Table of Contents
2
Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
1 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
5 Step by Step Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . .9
5.1 Document Symbols and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.2 Package Contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.3 System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.3.1 Charging the Handpieces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.3.2 Attaching Handpiece Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.3.2.1 Attaching Electric Heat Plugger (EHP) to Pack Handpiece . . . . . . . . . . . . . . . .13
5.3.2.2 Attaching Thermal Response Tip (TRT) to Pack Handpiece . . . . . . . . . . . . . . . 13
5.3.2.3 Attaching Heater (and GP cartridge) to Flow Handpiece. . . . . . . . . . . . . . . . .14
5.3.3 Programming the Handpieces — General Description . . . . . . . . . . . . . . 14
5.3.3.1 Programming the Pack Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
5.3.3.1.1 Programming the Pack Handpiece for the Thermal Response Tip (TRT) . . . . . . . . . . 17
5.3.3.2 Programming the Flow Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
5.3.4 Pack and Flow Handpieces — Common Features . . . . . . . . . . . . . . . . . 19
5.3.4.1 Pack Handpiece Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.3.4.2 Flow Handpiece Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Table of Contents
3
5.3.5 Handpiece Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.3.5.1 Pack Handpiece – Electric Heat Plugger (EHP) Operation . . . . . . . . . . . . . . . . 22
5.3.5.2 Pack Handpiece – Thermal Response Tip (TRT) Operation . . . . . . . . . . . . . . . 22
5.3.5.3 Flow Handpiece – Gutta-Percha (GP) Operation . . . . . . . . . . . . . . . . . . . . . . 23
5.3.5.4 Replacing the Flow Gutta-Percha (GP) Cartridge. . . . . . . . . . . . . . . . . . . . . .23
6 Cleaning, Disinfection and Sterilization . . . . . . . . . . . . . . . . 24
6.1 Forward . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6.2 Base Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6.3 Handpieces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6.4 Electric Heat Pluggers (EHP), Thermal Response Tips (TRT) and Flow Heaters
(HTR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
6.5 Gutta-Percha Cartridges (GP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
7 Supplies and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . .27
8 Technical Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . .28
9 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
10 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
11 Disposal of Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
12 Identication of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . 37

Introduction
4
FOR DENTAL USE ONLY
Introduction
Congratulations on your purchase of the Gutta‑Smart™ cordless obturation
system.
These Directions for Use are always kept up to date by Dentsply Sirona to bring
them in line with the latest developments. You will nd the current version on the
website shown on the back cover page of this manual.
In countries where the legal situation enables us to do so, we have decided not to
produce a printed version of the Directions for Use, for environmental reasons.
If no printed version is enclosed in your national language and you wish to have
a printed one, we will be happy to send you a copy (free of charge within seven
calendar days to any address in North America). To order, simply send your request
to the contact shown on the back cover page of this manual.
The Directions for Use are available in other languages on request. These Direc-
tions for Use have been compiled with the utmost care; nevertheless, it is not
always possible to completely rule out the risk of error, despite all eorts to do so.
We would appreciate your feedback in this area. If any errors are noted, please con-
tact Dentsply Sirona at the address shown on the back cover page of this manual.
Dentsply Sirona reserves the right to change the information and data contained
in the Directions for Use without prior notice.
1 Indications for use
The Gutta‑Smart™ is a cordless obturation system designed for warm vertical
obturation. The system contains handpieces that are used for down pack (Pack)
and backll (Flow) techniques to obturate the root canal system.
The Pack handpiece is intended to heat electric heat pluggers for warming and
softening gutta-percha master cones and searing o gutta-percha cones. This
handpiece is also intended to heat a thermal response tip that subjects a tooth to
heat in order to determine pulp vitality.
The Flow handpiece is intended for heating and extruding gutta-percha into the
root canal system. The single-use gutta-percha cartridges are designed to place
heated gutta-percha into a cleaned and shaped canal.
The Gutta‑Smart™ device can only be used with Dentsply Sirona gutta-percha
cartridges, ow heaters, electric heat pluggers and thermal response tips.
— Indications for use

Contraindications
5
2 Contraindications
Read the following contraindications before use.
• This device must not be used in cases where a patient has been tted with
an implanted heart pacemaker (or other electrical equipment) and has been
cautioned against the use of small electrical appliances (such as electric shavers,
hair dryers, etc.)
3 Warnings
Read the following warnings before use.
• This device is intended to be used for lling a root canal with gutta-percha and
provide a heated endodontic plugger for packing the root canal lling material
into place and may only be used by trained and qualied dentists.
• Do not use this device for any dental procedure other than root canal obtura-
tion.
• Do not use the device in the presence of free oxygen, ammable anesthetic gas
mixtures or ammable substances.
• The device can cause radio interference or disrupt the operation of equipment
in the vicinity. If this happens, the interference should be reduced by reorienting
or repositioning the device or by screening o the immediate environment. The
electromagnetic radiations emitted by the device are below the recommended
limits specied by the applicable relevant provisions (DIN EN 60601-1-2:2007).
During Treatment
• Gloves and a rubber dam are mandatory during treatment.
• If any irregularities with the device should occur during treatment, turn it o.
Contact Dentsply Sirona by phone or online at the contact information shown
on the back cover page of this manual, or contact your Dentsply Sirona autho-
rized service partner.
• Thermal hazard risk exists for patients.
• When replacing a gutta-percha cartridge during a procedure, the ow heater
sleeve and expended cartridge may be hot to the touch.
• Allow the ow heater to cool before attempting to remove.
• Do not remove a hot gutta-percha cartridge!
• Electric heat plugger tips become hot during use. Turn o unit and allow cool-
ing before exchanging tips.
— Warnings

Warnings
6
• The pack handpiece temperature must be set to 90°C when using the thermal
response tip to prevent overheating and patient injury.
• Using ngers or any other device other than the cannula bending tool to curve
the cannula can result in gutta-percha cartridge rupture or handpiece damage.
Repeated bending can damage the cannula.
• Do not stay in the root canal with a heated electric heat plugger tip for more
than 4 seconds to prevent thermal injury to the patient.
• Place gutta-percha on the thermal response tip before applying the tip to the
patient’s tooth. Do not place the tip directly on the tooth!
• Applying excessive downward pressure or not allowing the cannula to back out
of the canal may result in a dislocated cannula.
• Gutta-percha cartridges are for single patient use only.
• Gutta-percha cartridges cannot be reheated or reused.
• Do not use gutta-percha cartridges after the expiration date.
• Dispose of gutta-percha cartridges in a sharps receptacle.
Cleaning, Disinfection and Sterilization
• Do not use a disinfection solution for sterilization of gutta-percha cartridges.
• This equipment provides ordinary protection against harmful ingress of liquids.
Do not immerse the handpiece in any liquid or spray any uid directly onto the
handpiece.
• Do not immerse gutta-percha cartridges into any liquid.
• Use only the sterilization procedures as instructed in this manual. Other steriliza-
tion procedures may not be eective.
Repairs and Defects
• Do not use the device if you suspect damage or a defect.
• There are no serviceable components inside this unit. Do NOT Open!
• Repairs, alterations and modications to the device are not permitted unless
the manufacturer’s prior consent has been obtained. Dentsply Sirona cannot be
held liable if the device has been altered or modied. If a defect should occur,
contact Dentsply Sirona by phone or online at the contact information shown
on the back cover page of this manual, or contact your Dentsply Sirona autho-
rized service partner.

Warnings
7
Battery and Transport
• The battery charging connections on the handpieces are a proprietary connec-
tion. Only use the base station and power adapter supplied with the device to
charge the device. Use of non-original chargers jeopardizes the safety of the
patient and user.
• Intact devices can be transported by land freight or air freight in the original
packaging. The applicable requirements must be met.
• Defective devices can also be transported by air freight or land freight in the
original packaging. If the battery is defective, the device must not be transport-
ed by air freight under any circumstances.
• For international shipping of lithium-ion batteries, refer to the International Air
Transport Association (IATA) guidelines, located at http://www.iata.org/lithium-
batteries.
• For shipping of lithium-ion batteries within the United States, refer to the U.S.
Department of Transportation’s Pipeline and Hazardous Materials Safety Admin-
istration (PHMSA) site at http://www.phmsa.dot.gov/hazmat/guidance.

Precautions
8
4 Precautions
Read the following precautions before use.
• Place the cannula gently into the canal. Too much pressure will stop the motor
from turning.
• Do not charge, operate or store at high temperatures. Comply with the speci-
ed operating and storage conditions.
• Follow all local laws and regulations regarding the storage and shipment of
lithium-ion batteries.
• Always check to ensure that handpieces have a sucient battery charge before
starting treatment.
• Do not place the handpieces, charging base or gutta-percha cartridges in an
autoclave unit or washer-disinfector.
• Chemclaving is not recommended for sterilization and maintenance of the tips
as this would cause corrosion.
• If you use a disinfectant in the form of a spray, never spray the devices and
accessories directly. Instead, spray a paper towel with the surface disinfectant or
use a pre-moistened disinfectant towelette (wipe).
• The front end sealing caps should be used on the handpieces for wipe-down
cleaning to prevent moisture from entering the electronics.

Step by Step Instructions
9
5 Step by Step Instructions
SN
REF
132 C
°
xxx
C
°
P
Refer to chapters 3 Warnings and 4 Precautions to determine any special care
to exercise before starting to use the complete device.
Before use, please check the exact contents of the package. See 5.2 Package
Contents.
5.1 Document Symbols and Abbreviations
Symbol Identication
SN
REF
132 C
°
xxx
C
°
P
Consult instructions for use.
WARNING: Serious injury or death may result if ignored.
CAUTION: Damage to property or the environment may result if ignored.
Additional information, explanation on operation and performance.
GP Gutta-percha
EHP Electric heat plugger
TRT Thermal response tip
HTR Flow heater

Step by Step Instructions
10
5.2 Package Contents
Step Action
ACarefully remove the device and the accessories from their packaging and
place them on a at surface.
BCheck that the device is supplied with all the components listed below.
Flow Handpiece
Base Station
Pack Handpiece
Power Adapter
(100–240V, 50–60Hz)
Plug Adapters (used with Power Adapter) IEC Standards:
Type A Type C Type G Type I